efficacy and safety of alirocumab versus usual care on top of maximally tolerated statin therapy in patients with type 2 diabetes and mixed dyslipidemia (odyssey dm-dyslipidemia)

Conditions: Dyslipidemia

Summary: primary objective: to demonstrate the superiority of alirocumab in comparison with usual care in the reduction of non-high-density lipoprotein cholesterol (non-hdl-c) in participants with type 2 diabetes and mixed dyslipidemia at high cardiovascular risk with non-hdl-c not adequately controlled with maximally tolerated statin therapy. secondary objectives: * to demonstrate whether alirocumab is superior in comparison with usual care in its effects on other lipid parameters (ie, low-density lipoprotein cholesterol (ldl-c), apolipoprotein b (apo b), total cholesterol (total -c), lipoprotein a (lp\[a\]), high-density lipoprotein cholesterol (hdl-c), triglycerides (tgs), triglyceride rich lipoproteins (tgrls), apolipoprotein a-1 (apo a-1), apolipoprotein c-iii (apo c-iii), lipid subfractions by nuclear magnetic resonance (nmr) spectroscopy (ie, ldl-c particle size and ldl, very low-density lipoprotein \[vldl\], hdl, and intermediate-density lipoprotein \[idl\] particle number). * to assess changes in glycemic parameters with alirocumab vs. usual care treatment. * to demonstrate the safety and tolerability of alirocumab. * to evaluate treatment acceptance of alirocumab. * to evaluate proprotein convertase subtilisin kexin type 9 (pcsk9) concentrations and antibody development. * to demonstrate the superiority of alirocumab vs. fenofibrate on non-hdl-c and other lipid parameters (subgroup analysis).

the maximum study duration was approximately 9 months per participant, including a 6 month treatment period, a screening period of up to 3 weeks, and an 8 week safety observation period. for the purpose of scientific communication, a first-step analysis (both efficacy and safety) was performed at the week 24 cut-off date. a second-step analysis was performed once all participants had completed the study to include a final update of the safety analysis.

Eligibility criteria:
inclusion criteria: * participants with type 2 diabetes and mixed dyslipidemia whose non-hdl-c was not adequately controlled with a stable, maximum dose/regimen of statin that was tolerated by the participant. * 18 years of age or more. * documented history of atherosclerotic cardiovascular disease (ascvd) or at least one additional cardiovascular risk factor. * non-hdl-c of 100 mg/dl or greater. * triglycerides greater than or equal to 150 mg/dl and less than 500 mg/dl. * stable anti-hyperglycemic agents for at least 3 months prior to the screening visit and between screening and randomization (including stable insulin dose defined as no variation more than 30% in daily insulin dose within the preceding 3 months, as judged by the investigator). * no change in weight of more than 5 kg within the prior 3 months. * on stable dose of medications that are known to influence weight and/or lipids within the last 3 months. exclusion criteria: * use of any lipid modifying therapies other than statins within the last 4 weeks (eg, ezetimibe, fenofibrate, nicotinic acid, omega-3 fatty acids, etc.) or use of over the counter products/nutraceuticals known to impact lipids (eg, red yeast rice) within the last 4 weeks. * currently drinking more than 2 standard alcoholic drinks per day. * body mass index (bmi) \>45 kg/m² or currently enrolled in a weight loss program and still in active phase of weight loss. * glycosylated hemoglobin (hba1c) 9% or greater. the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.